Senior FDA consultant and specialist for medical device companies including HIPAA compliance and requirement management. Provides FDA pathway expertise, QSR compliance, cybersecurity guidance, and regulatory submission support. Use for FDA submission planning, QSR compliance assessments, HIPAA evaluations, and FDA regulatory strategy development.
Quick integration into your workflow with minimal setup
Active open-source community with continuous updates
MIT/Apache licensed for commercial and personal use
Customizable and extendable based on your needs
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Tip: Read the documentation and code carefully before first use to understand functionality and permission requirements
All Skills from open-source community, preserving original authors' copyrights
alirezarezvani__claude-skills/ra-qm-team/fda-consultant-specialist/skill.mdProven benefits and measurable impact
Access genomic data instantly without manual API calls or database navigation.
Automate queries to minimize human errors in gene/variant lookups.
Cut time spent on data gathering to focus on analysis and insights.
Perfect for these scenarios
Identify gene functions, pathways, and orthologs across 250+ species for research.
Predict functional impacts of genetic variants using VEP for clinical studies.
Compare genomes and sequences across species to study evolutionary relationships.
Analyze genetic variation patterns in populations for disease association research.